NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) announced the company's pneumococcal conjugate vaccine, Prevenar 13 or pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed], obtained European approval for an expanded indication to include adults aged 18 to 49 years for active immunization for the prevention of invasive disease caused by vaccine-type Streptococcus pneumoniae or S. pneumoniae.
Previously approved in the European Union or EU for use in infants, young children and adolescents aged 6 weeks to 17 years, as well as adults 50 years of age and older, Prevenar 13 is now the only pneumococcal vaccine in the EU that offers protection against invasive disease from infancy through adulthood.
The company said that the European Commission's decision to approve this label expansion for Prevenar 13 followed the submission and review of data from an open-label Phase 3 trial of the vaccine in healthy adults aged 18 to 49 years. The study - which met all primary and secondary objectives - showed that Prevenar 13 is at least as immunogenic in this age group as it is in adults 60 to 64 years of age, as measured one month after vaccination. Furthermore, Prevenar 13 showed a favorable safety profile and was generally well tolerated.
The company noted that Prevenar 13, or Prevnar 13 as it is called in the United States, Canada and Taiwan, was first introduced for use in infants and young children in December 2009 in the EU. It is now approved in more than 120 countries worldwide for use in infants and young children, and in more than 80 countries for use in adults 50 years of age and older.
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